ALPHARETTA, Ga., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that the official journal of The Royal College of Ophthalmologists, Eye, published a summary of critical insights into drug development and regulatory processes based on a presentation at the prestigious annual Edridge Green Lecture by Clearside’s Chief Medical Office ...

Shares of Clearside Biomedical, Inc. (CLSD) have been struggling lately and have lost 5.6% over the past two weeks. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road.While the formation of a hammer pattern is a technical indication of nearing a bottom with potential exhaustion of selling pressure, rising optimism among Wall Street analysts abo ...

Zacks Rating Upgrade - Clearside Biomedical has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a powerful force impacting stock prices [1] - The Zacks rating system is highly useful for individual investors as it tracks the Zacks Consensus Estimate for current and future years, providing a more objective measure compared to Wall Street analysts' subjective ratings [2][3] Earnings Estimate Revisions and Stock Price Correlation - Changes in a company's future earnings potential, reflected in earnings estimate revisions, are strongly correlated with near-term stock price movements [4] - Institutional investors use earnings estimates to calculate the fair value of a company's shares, and their bulk investment actions lead to price movements [4] - For Clearside Biomedical, rising earnings estimates and the consequent rating upgrade indicate an improvement in the company's underlying business, which should push the stock higher [5] Zacks Rank System and Earnings Estimate Revisions - The Zacks Rank system uses four factors related to earnings estimates to classify stocks into five groups, with Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [7] - Tracking earnings estimate revisions can be rewarding, as empirical research shows a strong correlation between these revisions and near-term stock movements [6] Clearside Biomedical's Earnings Estimates - For the fiscal year ending December 2024, Clearside Biomedical is expected to earn -$0.52 per share, a change of 1.9% from the year-ago reported number [8] - Over the past three months, the Zacks Consensus Estimate for Clearside Biomedical has increased by 6.6% [8] Zacks Rating System's Superiority - The Zacks rating system maintains an equal proportion of 'buy' and 'sell' ratings for its universe of over 4000 stocks, with only the top 5% receiving a 'Strong Buy' rating and the next 15% receiving a 'Buy' rating [9] - Clearside Biomedical's upgrade to a Zacks Rank 2 positions it in the top 20% of Zacks-covered stocks, indicating superior earnings estimate revision features and potential for market-beating returns in the near term [10]

Financial Data and Key Metrics - Cash and cash equivalents totaled approximately $23.6 million as of September 30, 2024, with sufficient resources to fund operations into Q3 2025 [35] - The company is planning for the CLS-AX Phase 3 program and research work to expand the pipeline into geographic atrophy [35] Business Line Data and Key Metrics - CLS-AX demonstrated an 84% reduction in injection frequency after the initial dose, with 90% of participants not requiring additional treatment for up to 4 months, 81% up to 5 months, and 67% up to 6 months [22] - The ODYSSEY Phase 2b trial showed stable best-corrected visual acuity (BCVA) and central subfield thickness (CST) over 36 weeks, with BCVA within two letters from baseline at weeks 24 and 36 [21] - The company is evaluating small molecules for geographic atrophy, a market valued at over $20 billion, focusing on improving choroidal perfusion and moderating inflammatory cells [10][31] Market Data and Key Metrics - The company's SCS Microinjector has been used in over 10,000 injections, with commercial approval for XIPERE, the first FDA-approved product for suprachoroidal administration [11] - Partnerships with Arctic Vision, Santen Pharmaceuticals, REGENXBIO, AbbVie, Aura Biosciences, and BioCryst Pharmaceuticals are advancing suprachoroidal delivery programs [13][15][17][18] Company Strategy and Industry Competition - The company is positioning CLS-AX as a maintenance treatment for wet AMD, offering flexible dosing between 3 to 6 months, which aligns with current physician practices [26] - The company is the only TKI wet AMD program with repeat dosing data, providing a competitive advantage as it advances CLS-AX into Phase 3 [9] - The company is expanding its suprachoroidal platform, with significant interest from retinal specialists and biopharmaceutical companies [12] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the potential of CLS-AX in the wet AMD market, with positive safety and efficacy data from the ODYSSEY trial [7][20] - The company is focused on advancing its Phase 3 program for CLS-AX and exploring new opportunities in geographic atrophy [26][31] - Management highlighted the strategic validation of the suprachoroidal delivery platform through partnerships with global pharmaceutical companies [14] Other Important Information - The company has made key personnel changes, including appointing Tony Gibney as Chair of the Board of Directors and expanding Victor Chong's role to include Head of Research and Development [36][38] - The company plans to present additional data from the ODYSSEY trial at upcoming medical conferences, including APVRS, Floretina, and angiogenesis meetings [55] Q&A Session Summary Question: Feedback on AAO presentation and study design incorporating retreatment - The data presented at AAO was well-received, with positive feedback on the flexibility of dosing and the ability to retreat with CLS-AX rather than using supplemental aflibercept [42][43][45] Question: Phase 3 trial design and geographic atrophy program expansion - The Phase 3 trial design will likely be similar to the aflibercept high-dose faricimab design, with flexible dosing and a non-inferiority margin of 4.5 letters [51][52] - The company is targeting an end-of-Phase 2 meeting with the FDA in early 2025 and plans to start the Phase 3 trial in the second half of 2025 [51][54] - The geographic atrophy program is focusing on small molecules that improve choroidal perfusion and moderate inflammatory cells [53] Question: Additional data analysis from ODYSSEY - The company plans to share more data at upcoming medical conferences, including APVRS, Floretina, and angiogenesis meetings, to clarify areas of confusion and provide additional analysis [55] Question: FDA concerns on redosing CLS-AX within six months - The company has no concerns regarding FDA approval for redosing CLS-AX within six months, as the Phase 2 trial already demonstrated the safety and efficacy of multiple redoses [60] Question: Estimated cost of the Phase 3 program - The cost of the Phase 3 program is still being finalized and will be clearer after the end-of-Phase 2 meeting with the FDA [61] Question: Mechanism of geographic atrophy and IND submission timeline - Geographic atrophy is considered a choroidal disease, with damage occurring before retinal pigment epithelium (RPE) cell death. The company is working on small molecules that target the choroid and retina [62][63] - The timeline for IND submission is still under development, but the company is moving toward specific candidates for advancement [66]

Clearside Biomedical, Inc. (CLSD) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 28.57%. A quarter ago, it was expected that this company would post a loss of $0.14 per share when it actually produced a loss of $0.10, delivering a surprise of 28.57%.Over the last four quarters, the company h ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 Clearside Biomedical, Inc. | --- | --- | |--------------------------------------------------------------------------------------------------------------- ...

Exhibit 99.1 Clearside Biomedical Announces Third Quarter 2024 Financial Results and Provides Corporate Update - Recent ODYSSEY Phase 2b Trial of Suprachoroidal CLS-AX in Wet AMD Achieved All Primary and Secondary Outcomes - - Positive Topline Results Support Advancing CLS-AX to Phase 3 Targeting a Differentiated Flexible Dosing Approach Similar to a Biologic with the Potential Extended Duration of a Tyrosine Kinase Inhibitor (TKI) - - Recent Commercial Licensing Agreement for China by a Global Ophthalmic P ...

ALPHARETTA, Ga., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today George Lasezkay, PharmD, JD, President and Chief Executive Officer, and Victor Chong, M.D., MBA, Chief Medical Officer and EVP, Head of Research & Development, will participate in a fireside chat at the Stifel 2024 Healthcare Conference on Tuesday, November 19, 2024 a ...

ALPHARETTA, Ga., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today the appointment of Tony Gibney as Chair of its Board of Directors, effective November 1, 2024. Mr. Gibney, who joined Clearside’s Board as an independent director in April 2024, succeeds Clay Thorp, who will continue serving as a member of the Board. George Lasezkay, ...

ALPHARETTA, Ga., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that its third quarter 2024 financial results will be reported on Tuesday, November 12, 2024 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. T ...